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Adenosine Cardioplegia; Improved Cardioprotection?

Primary Purpose

Angina Pectoris

Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Adenosine
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective patients
  • Ejection fraction > 40%
  • Age 40-75
  • No release og TnT or CKMB within last week before CABG
  • Pure CABG

Exclusion Criteria:

  • Age >75 or < 40
  • EF < 40%
  • Emergency operations
  • Unstable angina
  • Release of TnT or CKMB within the week before operation

Sites / Locations

  • University Hospital of North Norway

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adenosine cardioplegia

Control

Arm Description

Adenosine cardioplegia

Standard hyperkalemic cardioplegia

Outcomes

Primary Outcome Measures

Release of cardiac enzymes (TnT and CKMB)
Repeatedly measured postoperatively.

Secondary Outcome Measures

PiCCO
Measurement of cardiac function and hemodynamics the first 24 hours postoperatively
Endothelial injury
Measurements of markers of endothelial injury/dysfunction peroperatively. Blood will be sampled immediately before cross-clamping the aorta and after 5 minutes of reperfusion.

Full Information

First Posted
April 30, 2010
Last Updated
September 29, 2011
Sponsor
University Hospital of North Norway
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1. Study Identification

Unique Protocol Identification Number
NCT01123525
Brief Title
Adenosine Cardioplegia; Improved Cardioprotection?
Official Title
Adenosine Instead of Supranormal Potassium in Crystalloid Cardioplegia, a Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway

4. Oversight

5. Study Description

Brief Summary
60 elective patients for CABG will be included to receive either standard hyperkalemic cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive blood samples to measure release of cardiac enzymes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adenosine cardioplegia
Arm Type
Experimental
Arm Description
Adenosine cardioplegia
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard hyperkalemic cardioplegia
Intervention Type
Drug
Intervention Name(s)
Adenosine
Intervention Description
1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution
Primary Outcome Measure Information:
Title
Release of cardiac enzymes (TnT and CKMB)
Description
Repeatedly measured postoperatively.
Time Frame
First 48 hour postoperatively
Secondary Outcome Measure Information:
Title
PiCCO
Description
Measurement of cardiac function and hemodynamics the first 24 hours postoperatively
Time Frame
First 24 hours postoperatively
Title
Endothelial injury
Description
Measurements of markers of endothelial injury/dysfunction peroperatively. Blood will be sampled immediately before cross-clamping the aorta and after 5 minutes of reperfusion.
Time Frame
Peroperatively (before crossclamping aorta and after 5 minutes of reperfusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective patients Ejection fraction > 40% Age 40-75 No release og TnT or CKMB within last week before CABG Pure CABG Exclusion Criteria: Age >75 or < 40 EF < 40% Emergency operations Unstable angina Release of TnT or CKMB within the week before operation
Facility Information:
Facility Name
University Hospital of North Norway
City
Troomsø
ZIP/Postal Code
9038
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22964356
Citation
Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.
Results Reference
derived

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Adenosine Cardioplegia; Improved Cardioprotection?

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